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Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers

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ClinicalTrials.gov Identifier: NCT01229111
Recruitment Status : Terminated (Lack of Drug Supply)
First Posted : October 27, 2010
Results First Posted : March 29, 2017
Last Update Posted : March 29, 2017
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Primary Cholangiocellular Carcinoma
Advanced Adult Primary Liver Cancer
Cholangiocarcinoma of the Extrahepatic Bile Duct
Cholangiocarcinoma of the Gallbladder
Localized Unresectable Adult Primary Liver Cancer
Periampullary Adenocarcinoma
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Interventions: Drug: cediranib maleate
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from hospitals in Cleveland and Columbus, Ohio from October 2010 through February 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment (Cediranib Maleate and Modified FOLFOX)

Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.

cediranib maleate: Given PO

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV


Participant Flow:   Overall Study
    Treatment (Cediranib Maleate and Modified FOLFOX)
STARTED   14 
COMPLETED   13 
NOT COMPLETED   1 
Death                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All patients who signed consent.

Reporting Groups
  Description
Treatment (Cediranib Maleate and Modified FOLFOX)

Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.

cediranib maleate: Given PO

oxaliplatin: Given IV

leucovorin calcium: Given IV

fluorouracil: Given IV


Baseline Measures
   Treatment (Cediranib Maleate and Modified FOLFOX) 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age, Customized 
[Units: Participants]
 
30-39 years   1 
40-49 years   1 
50-59 years   3 
60-69 years   8 
70-79 years   1 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  78.6% 
Male      3  21.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      14 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   7.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  14.3% 
White      11  78.6% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures

1.  Primary:   The Response Rate of Patients Evaluated Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1   [ Time Frame: Up to 3 years ]

2.  Secondary:   Tabulation of the Toxicity Profile of the Combination Therapy   [ Time Frame: Up to 3 years ]

3.  Secondary:   Progression Free Survival   [ Time Frame: Up to 3 years ]

4.  Secondary:   Estimation of Overall Survival   [ Time Frame: Up to 3 years ]

5.  Secondary:   Identification of Factors That Predict Survival   [ Time Frame: Up to three years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Smitha Krishnamurthi
Organization: Case Comprehensive Cancer Center
phone: 216-844-5234
e-mail: smitha.krishnamurhti@uhhospitals.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01229111     History of Changes
Other Study ID Numbers: NCI-2011-02535
NCI-2011-02535 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000687126
CASE 9209 ( Other Identifier: Case Comprehensive Cancer Center )
8323 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
U01CA062502 ( U.S. NIH Grant/Contract )
First Submitted: October 26, 2010
First Posted: October 27, 2010
Results First Submitted: February 10, 2017
Results First Posted: March 29, 2017
Last Update Posted: March 29, 2017